FDA Orange Book · active-ingredient family
Ivermectin
Ivermectin is approved as 3 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOOLANTRA · NDA 206255
3
Brand (NDA)
12
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOOLANTRARLD | GALDERMA LABS LP | NDA 206255 | AB | Dec 19, 2014 | |
| SKLICERLD | ARBOR PHARMS LLC | NDA 202736 | — | Feb 07, 2012 | |
| STROMECTOLRLD×2 | MERCK SHARP DOHME | NDA 050742 | AB | Oct 08, 1998 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IVERMECTIN | AJANTA PHARMA LTD | ANDA 218509 | AB | Apr 07, 2026 | |
| IVERMECTIN | E5 PHARMA | ANDA 216808 | AB | Mar 09, 2026 | |
| IVERMECTIN | ZYDUS LIFESCIENCES | ANDA 216863 | AB | Feb 26, 2026 | |
| IVERMECTIN | EPIC PHARMA LLC | ANDA 218805 | AB | Sep 09, 2025 | |
| IVERMECTIN×2 | RUBICON RESEARCH | ANDA 215922 | AB | Jan 22, 2025 | |
| IVERMECTIN | SENORES PHARMS | ANDA 218324 | AB | Oct 16, 2024 | |
| IVERMECTIN | ZYDUS LIFESCIENCES | ANDA 215210 | AB | Aug 02, 2022 | |
| IVERMECTIN | TEVA PHARMS USA | ANDA 212485 | — | Mar 21, 2022 | |
| IVERMECTIN | TARO | ANDA 210720 | — | May 06, 2020 | |
| IVERMECTIN | PADAGIS ISRAEL | ANDA 210225 | AB | Apr 13, 2020 | |
| IVERMECTIN | TEVA PHARMS USA | ANDA 210019 | AB | Sep 13, 2019 | |
| IVERMECTIN | EDENBRIDGE PHARMS | ANDA 204154 | AB | Oct 24, 2014 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9233118 | Mar 13, 2034 | in 7 yr 10 mo | U-1631 |
| 9089587 | Mar 13, 2034 | in 7 yr 10 mo | U-1631 |
| 9233117 | Mar 13, 2034 | in 7 yr 10 mo | U-1631 |
| 9782425 | Mar 13, 2034 | in 7 yr 10 mo | U-1631 |
| 10206939 | Mar 13, 2034 | in 7 yr 10 mo | U-1631 |
Ivermectin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
